Newsweek Article Describes Disjointed System for Drug Development

If you’re like me, you find that you’re always waiting for announcements about new Alzheimer’s medications that are becoming available. But unfortunately, those announcements are few and far between. Why is that? In an article entitled “Desperately Seeking Cures,” Newsweek writers Sharon Begley and Mary Carmichael describe the disjointed process currently in place in trying to take scientific breakthroughs through to becoming a remedy for health issues. “Diseases are complicated, and nature fights every human attempt to mess with what she has wrought,” the pair wrote. “But frustration is growing with how few seemingly promising discoveries in basic biomedical science lead to something that helps patients, especially in what is supposed to be a golden age of genetics, neuroscience, and biomedical research in general.” This situation is happening during a period from 1998 to 2003 when the National Institute of Health (NIH) has had its budget doubled to $27 billion. NIH’s current budget is $31 billion.

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Here’s the disjointed development process that Begley and Carmichael described:

The first step involves academic researchers identifying a gene, protein or biological pathway that causes a disease. However, cures are not necessarily emerging from these breakthroughs. “The answer is that potential cures, or at least treatments, are stuck in the chasm between a scientific discovery and the doctor’s office: what’s been called the valley of death,” Begley and Carmichael explained. However, the system of honors, grants and tenure in academic and the NIH reward basic discoveries but not the extended work that turns these discoveries into medications.

The second step involves testing. “Should a lab be so fortunate as to discover a molecule that cures a disease in a lab rat, the next step is to test its toxicity and efficacy in more lab animals,” Begley and Carmichael wrote. “Without that, no company – for companies, not academic scientists, actually develop drugs – will consider buying the rights to it.” The NIH rarely supports this kind of research.

The third step after the tests on lab animals prove safe and effective is getting a patent. “For a multinational drug company to go forward, it needs patent protection in the U.S., as well (as in other countries)," the Newsweek authors wrote. However, issues can crop up such as the researcher’s publication of findings in a scientific paper (which is the way that academic researchers are rewarded in higher education), which can cause the U.S. patent office to reject an application.

Once patented, the next step involves the university or NIH technology-licensing office to identify a commercial partner to develop the professor’s discovery. “The institution where a scientist works, not the scientist herself, owns the intellectual-property rights to discoveries, and thus the exclusive right to license it,” the Newsweek authors wrote. The licensing process can be problematic when the company or institution does not have the cash necessary to pay required licensing fees demanded by the NIH’s licensing office.

Testing is next in line. “If a discovery is licensed, the licensee then has to raise enough money to test the compound’s toxicity (does it kill the lab rats? Give them seizures?), to figure out how to make it in quantity and with uniform quality, to test the drug in larger lab animals such as dogs, and then to test it in people,” Begley and Carmichael explained. “It is at this step – turning a discovery into something that can be manufactured and that is safe and effective – that the valley of death has gotten dramatically more fatal over the last few years.”

Begley and Carmichael wrote that a better pipeline will be created when academics, the NIH and disease foundations change how to operate. For instance, some private foundations are now managing and directing scientists more closely in the research process, requiring them to share data before publishing an article, to work together, and to take on the development work needed once a discovery is made. Different funding opportunities through NIH were created through the health-care reform bill that may help companies, academic researchers and advocacy groups take discoveries through “The Valley of Death.” And some universities are developing funding streams to help researchers take a discovery through the process so that eventually it may become a medication that can help people who are afflicted by the disease.